Efficacy, Safety, and Tolerability Study of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects With Recurrent C. Diff
- Conditions
- Clostridium Difficile Infection Recurrence
- Interventions
- Drug: Placebo
- Registration Number
- NCT03110133
- Lead Sponsor
- Finch Research and Development LLC.
- Brief Summary
Subjects with recurrent C. difficile infection will receive an oral dose of CP101 capsules one time in Treatment Group I or matching placebo one time in Treatment Group II. The purpose of this study is to demonstrate the safety and effectiveness of CP101 to prevent recurrence of C. difficile.
Subjects with confirmed C. difficile recurrence within 8 weeks after administration of study drug (CP101 or placebo) may be eligible to enroll in the open-label extension study (CP101-CDI-E02) and will receive CP101.
- Detailed Description
This is a Multicenter, Double-Blind, Parallel-Arm, Placebo-Controlled, Phase 2 Study of the Efficacy, Safety, and Tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in Subjects with Recurrence of Clostridium difficile Infection (CDI).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
- Ability to provide written informed consent
- Men or women 18 years of age or older
- Current diagnosis of a recurrence of non-severe, non-complicated CDI
- Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode
- Pregnant, breast-feeding, or considering becoming pregnant during the study
- Prior history, evidence, or diagnosis of inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis)
- Any prior diagnosis of diarrhea-predominant irritable bowel syndrome
- Systemic chemotherapy or radiation for the treatment of cancer during the 60 days prior to consent or planned during the 8 weeks following Randomization
- Prior fecal transplant for any condition, regardless of route of administration in the last year or plans to undergo during the study
- Major intra-abdominal surgery within the past 60 days prior to Screening
- History of total colectomy/ileostomy or bariatric surgery
- Admitted to, or expected to be admitted to an intensive care unit for any medical reason. Note: Residents of long term care facilities are eligible study entry
- Planned hospitalization or invasive surgery during the study
- Severe acute illness unrelated to CDI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CP101 Full Spectrum Microbiota Full Spectrum Microbiota Capsule Placebo Placebo Matching Placebo Capsule
- Primary Outcome Measures
Name Time Method Number of Participants With Occurrence of Treatment Emergent Adverse Events Week 8 Mapped to System Organ Class. Any adverse event (AE) reported that occurs during or post the administration of IP is defined as a Treatment Emergent AE (TEAE)
Number of Participants With Absence of Recurrence Through Week 8 Based on Adjudication Week 8 Defined in the protocol as sustained clinical cure
- Secondary Outcome Measures
Name Time Method Number of Participants With Absence of Recurrence Through Week 24 Based on Adjudication Week 24 Defined in the protocol as sustained clinical cure
Time to First Recurrent CDI Episode During the Study Week 8 The number of days between IP administration and the first C. Difficile recurrence
Number of Participants With Recurrence by Ribosomal NAP1/BI/027 C. Difficile Subtype Up to Week 8 NAP1 is the North American Pulse-field C. difficile subtype.
Trial Locations
- Locations (54)
Pinehurst
🇺🇸Pinehurst, North Carolina, United States
Calgary
🇨🇦Calgary, Alberta, Canada
Los Angeles
🇺🇸Los Angeles, California, United States
Bronx
🇺🇸Bronx, New York, United States
Poland
🇺🇸Poland, Ohio, United States
Bridgeport
🇺🇸Bridgeport, Connecticut, United States
Kinston
🇺🇸Kinston, North Carolina, United States
Evanston
🇺🇸Evanston, Illinois, United States
Toronto
🇨🇦Toronto, Ontario, Canada
Pinellas Park
🇺🇸Pinellas Park, Florida, United States
Grafton
🇺🇸Grafton, Wisconsin, United States
Ogden
🇺🇸Ogden, Utah, United States
Jacksonville
🇺🇸Jacksonville, Florida, United States
Naples
🇺🇸Naples, Florida, United States
Oakland
🇺🇸Oakland, California, United States
Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Chicago
🇺🇸Chicago, Illinois, United States
Indianapolis
🇺🇸Indianapolis, Indiana, United States
Boston
🇺🇸Boston, Massachusetts, United States
San Diego
🇺🇸San Diego, California, United States
Cincinnati
🇺🇸Cincinnati, Ohio, United States
Shawnee
🇺🇸Shawnee Mission, Kansas, United States
Murrieta
🇺🇸Murrieta, California, United States
Hamden
🇺🇸Hamden, Connecticut, United States
Burr Ridge
🇺🇸Burr Ridge, Illinois, United States
Maywood
🇺🇸Maywood, Illinois, United States
Royal Oak
🇺🇸Royal Oak, Michigan, United States
Butte
🇺🇸Butte, Montana, United States
St. Paul
🇺🇸Saint Paul, Minnesota, United States
Morristown
🇺🇸Morristown, New Jersey, United States
Somers Point
🇺🇸Somers Point, New Jersey, United States
New York
🇺🇸New York, New York, United States
Charlottesville
🇺🇸Charlottesville, Virginia, United States
Seattle
🇺🇸Seattle, Washington, United States
Halifax
🇨🇦Halifax, Nova Scotia, Canada
Atlanta
🇺🇸Atlanta, Georgia, United States
West Des Moines
🇺🇸West Des Moines, Iowa, United States
Providence
🇺🇸Providence, Rhode Island, United States
Annandale
🇺🇸Annandale, Virginia, United States
San Francisco
🇺🇸San Francisco, California, United States
Aurora
🇺🇸Aurora, Colorado, United States
Tampa
🇺🇸Tampa, Florida, United States
Detroit
🇺🇸Detroit, Michigan, United States
Rochester
🇺🇸Rochester, Minnesota, United States
Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
San Antonio
🇺🇸San Antonio, Texas, United States
Salt Lake City
🇺🇸Salt Lake City, Utah, United States
New Orleans
🇺🇸New Orleans, Louisiana, United States
Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Idaho Falls
🇺🇸Idaho Falls, Idaho, United States
Portland
🇺🇸Portland, Oregon, United States
Nashville
🇺🇸Nashville, Tennessee, United States
Scottsdale
🇺🇸Scottsdale, Arizona, United States
Washington DC
🇺🇸Washington, District of Columbia, United States